The following summary of S.510 reflects the manager’s amendment, as released by the Health, Education, Labor, and Pensions Committee on August 12, 2010.

Summary and Background

During the week of November 15th, the Senate may consider S.510, the FDA Food Safety Modernization Act. The Senate’s consideration of this legislation has been preceded by over a year of bipartisan work from, among others, Senators Durbin, Harkin,Dodd, Alexander, Burr, Gregg, and the late Senator Kennedy.

This bipartisan legislation would overhaul our current food safety system, which has failed to protect far too many Americans and will continue to fail them unless Congress improves the nation’s food safety laws. The legislation would address a number of the weaknesses of the current system by, among other provisions:

Giving the Food and Drug Administration (FDA) the authority to recall foods when firms fail to voluntarily recall products on their own, when a food is adulterated or contains undeclared allergens and will cause serious adverse health consequences or death to humans or animals;

Requiring the Secretary of Health and Human Services (HHS), within three years of enactment, to publish a notice of proposed rulemaking that would establish a national trace-back system;

Requiring food importers to perform food safety supplier verification activities and prohibit the importation of food by an importer if they do not undertake food safety supplier verification activities;

Expands the nation’s current food facility registration laws requiring all food facilities (excluding farms) to register with the FDA biennially and gives the FDA the authority and the assurance that it will be permitted to inspect registered facilities as permitted; and

Requires all registered domestic facilities (excluding farms) to identify known or reasonably foreseeable hazards and implement preventive controls to significantly minimize or prevent those identified hazards.

Requiring all food facilities to register and renew their registration biennially;

Granting FDA the authority to adjust food registration categories; and

Giving the Secretary of HHS the authority to suspend facility registration if there is a reasonable probability that food from the facility will cause serious adverse health consequences or death to humans or animals.

All registered domestic facilities to identify known or reasonably foreseeable hazards and implement preventive controls to significantly minimize or prevent those identified hazards; and

Each owner or operator to have a written plan describing their hazard analysis and preventative controls, which shall be made available to FDA upon request. Failure to comply with this section is a prohibited act under the Federal Food, Drug, and Cosmetic Act.

Section 104–performance standards. The FDA Food Safety Modernization Act would require the FDA, not less than every two years, to:

Determine the most significant food-borne contaminants; and

When appropriate, issue science-based guidance documents, action levels, and/or regulations in order to prevent and reduce the risk of serious illness or death, adulteration, or the spread of communicable disease.

Report to Congress on the activities of the government and private sector coordinating councils for agriculture and food defense, which are designed to improve information sharing between government and private sector partners in protecting the food system.

Promulgate regulations on the sanitary transportation of food pursuant to section 416(b) of the Federal Food, Drug, and Cosmetic Act.

Section 112–food allergy and anaphylaxis management in children. The FDA Food Safety Modernization Act directs HHS, in consultation with the Department of Education, to develop voluntary food allergy management guidelines to manage the risk of food allergy and anaphylaxis in schools or early childhood education programs. The legislation would also provide for non-renewable food allergy management incentive grants for up to two years to assist local educational agencies (LEAs) with adoption and implementation of the voluntary food allergy management guidelines.

Submit information to DEA if it denies a New Dietary Ingredient notification on the grounds that the dietary ingredient may contain an illegal steroid, and FDA must publish a guidance that clarifies regulation of new dietary ingredients in 180 days.

Conduct public health and cost assessments before issuing any guidance or rulemaking related to post harvest processing of raw oysters.

Section 115–port shopping. The FDA Food Safety Modernization Act would require that until FDA publishes its final rule on the marking of food imports that are refused entry into the United States (as required by the Bioterrorism Act) that the FDA:

Notify DHS of all instances in which it refuses to admit a food into the United States so that DHS, acting through Customs and Border Protection, can notify all ports in the United States and thereby prevent food that is refused in one port from being admitted into the country by another.

Recognize laboratory accreditation bodies that accredit food testing laboratories and to establish a publicly available registry of those bodies;

Require all laboratory testing done for FDA regulatory purposes to be conducted by either an FDA lab or a lab accredited by an FDA-recognized accreditation body; and

Require a report to Congress on the implementation of the national laboratory Food Emergency Response Network to support early detection, rapid response, and management of food-related emergencies.

Section 203–integrated consortium of laboratory networks. The FDA Food Safety and Modernization Act would require DHS to work with HHS, Department of Agriculture (USDA), and the Environmental Protection Agency (EPA) to effectively integrate laboratory networks and other relevant data sources to optimize national preparedness by:

Quickly sharing information;

Conducting analyses; and

Alerting responders.

Section 204–enhancing traceback and recordkeeping. The FDA Food Safety and Modernization Act would require the FDA, in coordination with the produce industry, to:

Establish pilot projects to test and evaluate new methods for rapidly and effectively tracking and tracing fruits and vegetables;

Ensure that methods are appropriate for small businesses; and

After completion of the pilot project, to establish standards for the types of information, information format, and timeframes for submission of food records to aid the Secretary in rapidly performing trace back activities in the event of a food-borne illness outbreak.

Section 205–pilot project to enhance traceback and recordkeeping with respect to processed food. The FDA Food Safety and Modernization Act would require the Secretary of HHS to establish a pilot project to:

Explore and evaluate methods for rapidly and effectively tracking and tracing processed food, so that, if an outbreak which involves processed food occurs, the source of the outbreak and recipients of the contaminated food may be quickly identified.

Require the Secretary to enhance food-borne illness surveillance systems to improve the collection, analysis, reporting, and usefulness of data on food-borne illnesses;

Establish a diverse working group of experts and stakeholders from federal, state, and local food safety and health agencies, the food industry, consumer organizations, and academia to provide recommendations on an ongoing basis regarding the improvement of food-borne illness surveillance; and

Require the Secretary to develop and implement strategies to leverage and enhance the food safety and defense capacities of state and local agencies.

Order food recalls when firms fail to voluntarily recall products on their own, or when a food is adulterated or contains undeclared allergens and will cause serious adverse health consequences or death to humans or animals.

Enter into agreements and arrangements with foreign governments to facilitate the inspection of foreign facilities; and

Refuse entry of food from a foreign facility or country that fails to permit inspection by the United States.

Section 307–accreditation of third-party auditors and audit agents. The FDA Food Safety and Modernization Act would direct the FDA to:

Recognize accreditation bodies to accredit third parties to certify that foreign food facilities are in compliance with U.S. food safety standards; and

Use third party certification for participation in the Voluntary Qualified Importer Program or to fulfill import certification requirements established by the FDA.

Section 308–foreign offices of the FDA. The FDA Food Safety and Modernization Act would direct the FDA to:

Establish offices in at least five foreign nationsto improve the agency’s presence overseas and positively impact the safety of FDA-regulated products.

Section 309–smuggled food. The FDA Food Safety and Modernization Act would require the Secretary of HHS to consult with the Secretary of DHS, Commissioner of Customs and Border Protection, and the Assistant Secretary for Immigration and Customs Enforcement to:

Develop and implement a strategy to better identify smuggled food and prevent its entry into the United States.

On March 3, 2009, S.510 was introduced by Senator Durbin and the bill was referred to the Health, Education, Labor, and Pensions Committee. When introduced, the bill enjoyed bipartisan support and six original cosponsors: Senators Dodd, Kennedy, Alexander, Burr, Gregg, and Isakson.

On November 18, 2009, the Health, Education, Labor, and Pensions Committee approved the legislation by voice vote.

On December 18, 2009, the Health, Education, Labor, and Pensions Committee reported the legislation to the Senate floor with an amendment. When placed on the Senate calendar, the legislation had garnered further bipartisan support with nine additional cosponsors: Senators Bingaman, Burris, Gillibrand, Harkin, Klobuchar, Udall (NM), Chambliss, Enzi, and Hatch.

The Health, Education, Labor, and Pensions Committee released a Manager’s Amendment to S.510 on August 12, 2010.